Remifentanil and Midazolam on Propofol for Loss of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-05-31

Brief Summary

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Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect.

The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.25 mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive 0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success' is defined as loss of both verbal response and eyelash reflex in 2 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.25 mg/kg higher dose of propofol at induction period.

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Detailed Description

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Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect. There are not many studies which provide minimum dose of propofol to induce hypnosis in combination with these agents and advantage of the combination.

The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided due to the previous studies which have mentioned 40 participants as a adequate sample size for this biased coin design - up and down study.

After receiving informed consent, patients will be participated in this study. No premedication will be given to the patients before induction. The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.25 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.03 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 1 mg/kg in each group and the dose will be changed by the result of prior study participant.

'Success' of this study will be defined as loss of both verbal response and eyelash reflex in 2 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.25 mg/kg higher dose of propofol at induction period.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group P

Induction with propofol bolus. Dose will be started at 1 mg/kg and will be adjusted as described in summary.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.

Group PR

Induction with propofol and remifentanil. Remifentanil infusion 0.25 mcg/kg/min for 5 min followed by propofol bolus Propofol dose will be started at 1 mg/kg and will be adjusted as described in summary.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.

Remifentanil

Intervention Type DRUG

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.

Group PMR

Induction with propofol, midazolam and remifentanil. Remifentanil infusion 0.25 mcg/kg/min for 5 min followed by midazolam 0.03 mg/kg bolus 1 min after remifentanil infusion start and propofol bolus administration.

Propofol dose will be started at 1 mg/kg and will be adjusted as described in summary.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.

Remifentanil

Intervention Type DRUG

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.

Midazolam

Intervention Type DRUG

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.03 mg/kg administration 1 min after remifentanil infusion start.

Interventions

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Propofol

Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.

Intervention Type DRUG

Remifentanil

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.

Intervention Type DRUG

Midazolam

Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.03 mg/kg administration 1 min after remifentanil infusion start.

Intervention Type DRUG

Other Intervention Names

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Fresofol Ultiva Vascam

Eligibility Criteria

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Inclusion Criteria

* The patients who are scheduled to undergo general anesthesia for a surgery.

Exclusion Criteria

1. ASA class (American Society of Anesthesiologist physical status classification) II or higher
2. Patients with history of allergy or side effects on propofol, remifentanil, midazolam
3. BMI (body mass index) less than 20 or higher than 30
4. Pregnancy
5. Patients taking sedatives or hypnotic agents.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No